Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The complete response to the preventive treatment of nausea and vomiting
研究概览
简要总结
Poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. Metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor compliance, a deterioration in the general condition or even prolongation of hospitalizations and a delay in the implementation of chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests above all on their prevention. At present and in most centers, the prevention of nausea and vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively on drug treatments, according to a protocol established according to the emetogenic risk of the chemotherapy received.
We propose a study evaluating the effectiveness of the stimulation of acupuncture points by low frequency laser therapy associated with antiemetics in the management of chemotherapy induced nausea and vomiting in patients of 2 to 20 years followed in the service of analgesics. pediatric onco-hematology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of malignant pathology with indication of chemotherapy with moderate to severe emetogenic potential
- •Indication of at least three identical chemotherapy cures
- •Age between 2 and 20 years
- •Prescription of an anti emetic protocol
- •Karnosky / Lansky Index> 60%
排除标准
- •Proven laser contraindication
- •Vomiting in the 24 hours before starting treatment
- •Presenting a brain lesion responsible for nausea and vomiting
- •Pelvic abdominal irradiation the week before the start of treatment
- •Treatment with benzodiazepines or opioids the week before treatment
- •Pregnant women
结局指标
主要结局
The complete response to the preventive treatment of nausea and vomiting
时间窗: Hours 72 after the end of chemotherapy
The complete response to the preventive treatment of nausea and vomiting defined by the absence of vomiting (active rejection by the mouth of part of the contents of the stomach), absence of nausea (effort of vomiting without active rejection) and the lack of emergency antiemetic treatment during the acute and delayed phase of chemotherapy (from the onset of chemotherapy to H72 after the end of chemotherapy).
次要结局
未报告次要终点